Barbiturate Drug Class List

Drugs in Drug Class: Barbiturate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	BREVITAL SODIUM	methohexital sodium	INJECTABLE;INJECTION	011559-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Endo Operations	BREVITAL SODIUM	methohexital sodium	INJECTABLE;INJECTION	011559-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Endo Operations	BREVITAL SODIUM	methohexital sodium	INJECTABLE;INJECTION	011559-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Larken Labs Inc	ALLZITAL	acetaminophen; butalbital	TABLET;ORAL	203484-001	Dec 4, 2015	AA	RX	No	Yes

Barbiturate Market Analysis and Financial Projection

The barbiturate drugs market is experiencing steady growth despite historical declines, driven by evolving therapeutic applications and innovations in drug formulations. While once widely prescribed for anxiety and sleep disorders, barbiturates now occupy a niche role in treating conditions like epilepsy, supported by technological advancements and shifting demographics. Below is a detailed analysis of market dynamics and the patent landscape shaping this sector:

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Market Dynamics

Growth Drivers

• Neurological Disorder Prevalence: Rising global cases of epilepsy, insomnia, and anxiety are fueling demand. Over 40% of the global population experiences neurological conditions, with projections suggesting this burden will double by 2050[2][9][12].
• Aging Populations: By 2032, 22% of the global population will be over 60, increasing reliance on medications for age-related neurological issues[7][9].
• Innovative Drug Delivery: Novel systems, such as nanotechnology and targeted release mechanisms, enhance efficacy while minimizing sedation risks. Non-sedating barbiturates (e.g., US-7723346-B2) exemplify this trend, offering neuroprotection without anesthesia[4][7].

Market Segmentation

Category	2023 Value	2032 Projection	Key Insights
Drug Type	Long-acting (USD 200M)	USD 274.7M	Dominates due to prolonged effects for epilepsy management[2][12].
Application	Epilepsy (USD 303M)	USD 613M	Phenobarbital remains critical for seizure control[2][7].
Distribution	Retail Pharmacies	USD 274.7M	Accessibility and affordability drive uptake[2][12].

Regional Trends

• North America: Held 40% market share (USD 191.6M in 2023) due to high healthcare spending and advanced R&D[5][7].
• Asia-Pacific: Fastest-growing region (CAGR 3.9%) spurred by rising epilepsy cases in India and China[5][7].

Challenges

• Safety Concerns: High overdose risk and addiction potential led to benzodiazepines displacing barbiturates in many applications[3][12].
• Regulatory Scrutiny: Stricter prescribing guidelines limit use, though teen misuse of phenobarbital is resurging[3][12].

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Patent Landscape

Key Innovations

1. Non-Sedating Barbiturates (US-7723346-B2): Neuroprotective agents using diphenylbarbituric acid derivatives to avoid sedation[4].
2. Ultrashort-Acting Hypnotics (US20030100575A1): Rapid-onset formulations for procedural sedation[10].
3. Detection Technologies:
   • Assay Kits (US6472227B1): Enable rapid barbiturate testing in bodily fluids[6].
   • Keratin Analysis (US6949344): Detects drug residues in hair/nails[1].

Patent Challenges

• Price Reduction Impact: Invalidating low-quality patents (e.g., Zytiga’s 97% price drop post-PTAB review) shows potential for generic competition[11].
• Expired Patents: Multiple barbiturate assay patents (e.g., US5096838A) have expired, lowering barriers for generic entrants[8][11].

Strategic Moves

• Acquisitions: Companies like Par Pharmaceutical expand market reach through mergers[12][14].
• Geographic Expansion: Focus on Asia-Pacific to address high unmet needs in epilepsy care[5][7].

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Future Outlook

The market is projected to reach USD 675M by 2034 (CAGR 3.2%), driven by:

• Neurological Epidemic: Alzheimer’s and Parkinson’s cases doubling by 2050[2][9].
• Policy Support: Governments prioritizing mental health funding in low-income regions[7][14].
• Generics Competition: Patent challenges could reduce costs, improving access in emerging markets[11][13].

"Enhancements in barbiturate formulations are revolutionizing sleep disorder therapeutics while addressing safety concerns." – Polaris Market Research[9].

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Key Takeaways

• Barbiturates remain vital for epilepsy and niche sedation uses despite historical misuse.
• Patent innovations focus on reducing sedation risks and improving detection.
• Market growth hinges on balancing regulatory oversight with accessibility in aging populations.

References

1. https://patents.justia.com/patents-by-us-classification/436/816
2. https://www.gminsights.com/industry-analysis/barbiturate-drugs-market
3. https://www.webmd.com/mental-health/addiction/barbiturate-abuse
4. https://pubchem.ncbi.nlm.nih.gov/patent/US-7723346-B2
5. https://www.grandviewresearch.com/industry-analysis/barbiturate-drugs-market-report
6. https://patents.google.com/patent/US6472227B1/en
7. https://www.pharmiweb.com/press-release/2024-12-05/global-barbiturate-drug-market-projected-to-reach-usd-6750-million-by-2034
8. https://patents.google.com/patent/US5096838A/de
9. https://www.polarismarketresearch.com/press-releases/barbiturate-drugs-market
10. https://patents.google.com/patent/US20030100575A1/en
11. https://patentprogress.org/2024/05/how-challenging-low-quality-patents-is-lowering-drug-prices/
12. https://www.mordorintelligence.com/industry-reports/barbiturate-drugs-market/market-size
13. https://journals.plos.org/plosmedicine/article/file?id=10.1371%2Fjournal.pmed.1004540&type=printable
14. https://www.polarismarketresearch.com/industry-analysis/barbiturate-drugs-market